Artificial intelligence (AI) is rapidly transforming healthcare, with new developments spanning clinical workflows, diagnostics, patient engagement, and regulatory oversight. At the recent AI Summit, panelists discussed the complexities of complying with the European Union’s AI Act and global regulatory frameworks, as well as emerging data privacy risks and reimbursement strategies for innovative health technologies. In the United States, the Food and Drug Administration (FDA) has begun integrating generative AI tools into its regulatory review process. Following a successful pilot at the Center for Drug Evaluation and Research, the FDA aims for all product centers to deploy AI platforms by June 30, 2025. The rollout is led by Chief AI Officer Jeremy Walsh and Senior Advisor Sridhar Mantha. These tools are designed to support, not replace, human reviewers, streamlining document analysis and improving review efficiency. AI is enabling advances in preventive healthcare, with tools that help primary care physicians identify at-risk patients and manage chronic conditions among the 194 million U.S. adults living with at least one chronic disease. AI-powered electronic health records (EHRs) and documentation assistants are reducing administrative burdens, allowing clinicians to focus more on patient care and prevention. Recent innovations include a fully AI-driven robotic IVF procedure by Conceivable Life Sciences, resulting in the birth of a baby without human intervention in the fertilization process. In diagnostics, a system developed by Prince Sultan and Menoufia Universities achieved 93% accuracy in detecting lung cancer from CT scans, and the Multimodal Medical Concept Bottleneck Model has demonstrated ophthalmologist-level precision in diagnosing rare eye cancers. AI-powered brain-computer interfaces at UC San Francisco have enabled a paralyzed man to control a robotic arm using brain signals, and a sign language translator developed at Florida Atlantic University achieved 98.2% accuracy. AI is also streamlining prostate pathology data extraction and advancing cardiac imaging and risk prediction. Legal experts caution that as AI automates patient communications, healthcare organizations must comply with regulations such as the Telephone Consumer Protection Act (TCPA) and the Health Insurance Portability and Accountability Act (HIPAA). Recent FCC rulings clarify that AI-generated voices are subject to TCPA consent requirements, and companies are advised to audit their consent protocols and monitor ongoing litigation.